NCT01075282

Brief Summary

The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
810

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
20 countries

78 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 16, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

2.2 years

First QC Date

February 23, 2010

Results QC Date

October 3, 2014

Last Update Submit

January 15, 2015

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

    Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.

    Baseline, 52 weeks

Secondary Outcomes (25)

  • Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

    Baseline, 26 weeks, and 78 weeks

  • Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks

    26, 52, and 78 weeks

  • Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks

    26, 52, and 78 weeks

  • Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

    Baseline, 26, 52, and 78 weeks

  • Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)

    Baseline, 52, and 78 weeks

  • +20 more secondary outcomes

Study Arms (3)

LY2189265 1.5 mg

EXPERIMENTAL

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks

Drug: LY2189265Drug: MetforminDrug: Glimepiride

LY2189265 0.75 mg

EXPERIMENTAL

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks

Drug: LY2189265Drug: MetforminDrug: Glimepiride

Insulin Glargine

ACTIVE COMPARATOR

Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks

Drug: Insulin GlargineDrug: MetforminDrug: Glimepiride

Interventions

Insulin GlargineDRUG
Insulin Glargine
LY2189265DRUG
Also known as: Dulaglutide
LY2189265 0.75 mgLY2189265 1.5 mg
MetforminDRUG
Insulin GlargineLY2189265 0.75 mgLY2189265 1.5 mg
GlimepirideDRUG
Insulin GlargineLY2189265 0.75 mgLY2189265 1.5 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)
  • Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
  • HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
  • Accept treatment with metformin and glimepiride throughout the study, as per protocol
  • Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.
  • Stable weight for 3 months prior to screening
  • Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2)
  • Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug

You may not qualify if:

  • Type 1 Diabetes
  • HbA1c equal to or less than 6.5 at randomization
  • Chronic insulin use
  • Taking drugs to promote weight loss by prescription or over the counter
  • Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
  • History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening
  • Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
  • Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit
  • Acute or chronic pancreatitis of any form
  • Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)
  • History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
  • A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening
  • Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
  • History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
  • Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (78)

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Buenos Aires, C1425AGC, Argentina

Location

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Caba, C1417EYG, Argentina

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Córdoba, 5006, Argentina

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Mendoza, 5500, Argentina

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Wollongong, New South Wales, 2500, Australia

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Brisbane, Queensland, 4029, Australia

Location

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Keswick, South Australia, 5035, Australia

Location

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East Ringwood, Victoria, 3135, Australia

Location

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Heidelberg, Victoria, 3081, Australia

Location

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Gribomont, 6887, Belgium

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Halen, 3545, Belgium

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Leuven, 3000, Belgium

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Joinville, 89201-260, Brazil

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São Paulo, 05403-900, Brazil

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Edmonton, Alberta, T5J 3N4, Canada

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Coquitlam, British Columbia, V3K 3P4, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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St. John's, Newfoundland and Labrador, A1E 2C2, Canada

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Markham, Ontario, L6B 0P9, Canada

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Mississauga, Ontario, L5M 2V8, Canada

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Montreal, Quebec, H2W 1R7, Canada

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Sherbrooke, Quebec, J1G 5K2, Canada

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Osijek, 31000, Croatia

Location

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Slavonski Brod, 35 000, Croatia

Location

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Zagreb, 10000, Croatia

Location

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Holešov, 769 01, Czechia

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Prague, 140 59, Czechia

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Corbeil-Essonnes, 91106, France

Location

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Dijon, 21079, France

Location

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Nantes, 44093, France

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Pessac, 33604, France

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Tours, 37044, France

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Athens, 11527, Greece

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Budapest, 1036, Hungary

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Makó, 6900, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Székesfehérvár, 8000, Hungary

Location

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Aligarh, 202002, India

Location

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Bangalore, 560003, India

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Chennai, 600029, India

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Indore, 452002, India

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Jaipur, 302001, India

Location

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Mumbai, 400053, India

Location

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Patna, 800 020, India

Location

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Florence, 50141, Italy

Location

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Milan, 20132, Italy

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Coatzacoalcos, 96400, Mexico

Location

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Cuernavaca, 62250, Mexico

Location

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Guadalajara, 44656, Mexico

Location

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Monterrey, 64570, Mexico

Location

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Bialystok, 15-404, Poland

Location

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Bydogoszcz, 85-094, Poland

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Krakow, 31-261, Poland

Location

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Szczecin, 71-455, Poland

Location

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Warsaw, 02-507, Poland

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Wroclaw, 50-127, Poland

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Baia Mare, 430123, Romania

Location

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Bucharest, 020045, Romania

Location

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Galati, 800587, Romania

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Oradea, 410025, Romania

Location

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Košice, 04001, Slovakia

Location

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Bucheon-si, 420-717, South Korea

Location

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Ilsan, 411706, South Korea

Location

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Pusan, 614-735, South Korea

Location

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Alicante, 03114, Spain

Location

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Ávila, 05004, Spain

Location

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Palencia, 34005, Spain

Location

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Requena, 46340, Spain

Location

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Gothenburg, 41345, Sweden

Location

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Helsingborg, 25187, Sweden

Location

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Lund, 22185, Sweden

Location

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Stockholm, 11157, Sweden

Location

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Chiayi City, 600, Taiwan

Location

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Kaohsiung City, 807, Taiwan

Location

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Tainan, 70403, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taipei, 11031, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taoyuan District, 333, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Yung-Kang, Tainan, 710, Taiwan

Location

Related Publications (3)

  • Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

    PMID: 27161178DERIVED

  • Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

    PMID: 26691396DERIVED

  • Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18.

    PMID: 26089386DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin GlarginedulaglutideMetforminglimepiride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsBiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 25, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2012

Study Completion

November 1, 2012

Last Updated

January 16, 2015

Results First Posted

January 16, 2015

Record last verified: 2015-01

Locations

CZ(2)KR(3)TW(6)RO(4)CR(3)ME(4)FR(5)GR(1)AU(5)SL(1)SE(4)IT(2)AR(4)BR(2)IN(7)BE(3)ES(4)HU(4)PL(6)CA(8)